Bioequivalence study of bisoprolol fumarate hydrochlorothiazide 10.25 mg tablets of Sami Saz pharmaceutical company compared to samples of bisoprolol fumarate 10 mg from Merck Germany and hydrochlorthiazide 25 mg from Juvise France on healthy volunteers
Bioequivalence study of bisoprolol fumarate hydrochlorothiazide 10/25 mg tablets of Sami Saz pharmaceutical company compared to samples of bisoprolol fumarate 10 mg from Merck Germany and hydrochlorthiazide 25 mg from Juvise France on healthy volunteers
Design
The current clinical trial includes the bioequivalence study of bisoprolol fumarate hydrochlorothiazide 10/25 mg tablets of Sami Saz Pharmaceutical Company compared to samples of bisoprolol fumarate 10 mg from Merck, Germany and hydrochlorthiazide 25 mg from Juvise, France, after administration to 24 healthy human volunteers, in two intervention groups, in a cross-over manner. , is not blinded and non-randomized.
Settings and conduct
The study is carried out at Nik Azma Pars Alborz Company, located in Mahdasht Karaj, Imam Khomeini Blvd., Azadegan Square, No. 419. The blinded cross-over study includes two stages (oral consumption of one tablet of bisoprolol fumarate hydrochlorothiazide 10/25 mg per study and a total of 2 times) with a one-week washout period on 24 fasting healthy volunteers. Then the obtained blood samples is analyzed.
Participants/Inclusion and exclusion criteria
Inclusion criteria: healthy volunteers between the ages of 18 and 55 should be non-smokers.
Exclusion criteria: volunteers with blood pressure less than 90 over 60 mm Hg or higher than 140 over 90 mm Hg.
Intervention groups
The study includes two stages as intervention 1: including oral intake of bisoprolol fumarate hydrochlorothiazide 10/25 mg tablets manufactured by Sami Saz Pharmaceutical Company of Iran and intervention 2: oral intake of bisoprolol fumarate tablets 10 mg manufactured by Merck Co., Germany and hydrochlorthiazide 25 mg manufactured by Iran Juvise is a French company. This study will be repeated on fasting volunteers in a cross-sectional manner with an interval of one week.
Main outcome variables
Maximum plasma concentration
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230222057495N9
Registration date:2023-08-19, 1402/05/28
Registration timing:registered_while_recruiting
Last update:2023-08-19, 1402/05/28
Update count:0
Registration date
2023-08-19, 1402/05/28
Registrant information
Name
Monireh Jalalipour
Name of organization / entity
Nikazma Pars Alborz company
Country
Iran (Islamic Republic of)
Phone
+98 26 3731 8748
Email address
info@naplab.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-11, 1402/05/20
Expected recruitment end date
2024-08-10, 1403/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Bioequivalence study of bisoprolol fumarate hydrochlorothiazide 10.25 mg tablets of Sami Saz pharmaceutical company compared to samples of bisoprolol fumarate 10 mg from Merck Germany and hydrochlorthiazide 25 mg from Juvise France on healthy volunteers
Public title
Bioequivalence study of bisoprolol fumarate hydrochlorothiazide tablet 10/25 mg
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Healthy volunteers aged between 18 and 55 years
Body mass index less than 30 kg per square meter
All candidates must be non-smokers
Exclusion criteria:
Blood pressure less than 90 on 60 mm Hg or more than 140 on 90 mm Hg.
Consumption of any drugs, alcohol or tobacco products within 2 weeks before receiving the drug
Age
From 18 years old to 55 years old
Gender
Both
Phase
Bioequivalence
Groups that have been masked
No information
Sample size
Target sample size:
24
More than 1 sample in each individual
Number of samples in each individual:
30
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Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Institute of Pharmaceutical Sciences, Tehran University of Medical Sciences
Street address
Institute of Pharmaceutical Sciences, Faculty of Pharmacy, Tehran University of Medical Sciences, Porsina Street
City
Tehran
Province
Tehran
Postal code
1417613151
Approval date
2023-07-31, 1402/05/09
Ethics committee reference number
IR.TUMS.TIPS.REC.1402.060
Health conditions studied
1
Description of health condition studied
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ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Maximum plasma concentrations of bisoprolol fumarate and hydrochlorothiazide
Timepoint
Before taking the medicine and: 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 7, 9, 10, 24, 34 and 48 hours after taking the medicine.
Method of measurement
Liquid chromatography-mass spectrometry
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: includes the oral intake of bisoprolol fumarate hydrochlorothiazide 10.25 mg tablets of Sami Saz Pharmaceutical Company of Iran on 24 fasting healthy volunteers. 5 ml of blood was taken from the volunteers at time intervals before starting to take the drug and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 7, 9, 10, 24, 34 and 48 hours after taking the drug. can be The cross-over study consists of two phases (oral administration of one tablet of bisoprolol fumarate hydrochlorothiazide 10.25 mg per study and a total of 2 times) with a one-week washout period (when the drug is completely removed from your blood). . Determination of plasma concentration of bisoprolol fumarate and hydrochlorothiazide is done by liquid chromatography mass-spectrometry method. The analysis of the results will be based on ANOVA and t-test statistical methods.
Category
Other
2
Description
Intervention group 2: includes the oral intake of bisoprolol fumarate 10 mg tablets from Merck, Germany and hydrochlorthiazide 25 mg from Juvise, France on 24 healthy fasting volunteers. 5 ml of blood was taken from the volunteers at time intervals before starting to take the drug and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 7, 9, 10, 24, 34 and 48 hours after taking the drug. can be The cross-over study consists of two phases (oral administration of one tablet of bisoprolol fumarate hydrochlorothiazide 10.25 mg per study and a total of 2 times) with a one-week washout period (when the drug is completely removed from your blood). . Determination of plasma concentration of bisoprolol fumarate and hydrochlorothiazide is done by liquid chromatography mass-spectrometry method. The analysis of the results will be based on ANOVA and t-test statistical methods.